BEUDAMED
    FDA Recall Terminated

    Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain

    Recall: Z-0075-2008 · Initiated August 1, 2007

    Recall

    Recall Number
    Z-0075-2008
    Event Number
    44813
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KXJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 1, 2007
    Posted
    November 8, 2007
    Terminated
    March 2, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain

    Reason

    Design Problems Including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potenti

    Action

    Recalling firm initiated correction by visit on August 2007. Corrections include replacement of one or more of the following: charger board, pin lodging, rear bumper. Also, replace the interface board and remove resistor mounted on chassis, remove brake pedal and assembly of cosmetic brake or apply caution labels.

    Distribution

    Class II Recall - Worldwide Distribution --- USA including States of -- AL, CA, FL, GA, IA, IL, IN, LA, ND, NY, OH, PA, TX, and WI, and Countries of -- BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GUAYANA, HONG KONG, HUNGARY, IRELAND, ISRAEL, ITALY, KUWAIT, LATVIA, LEBANON, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    96